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Elvina Almuradova/LinkedIn
Feb 26, 2025, 10:59
Elvina Almuradova: How GEMSTONE-303 differs from other trials
Elvina Almuradova, Associate Professor of Oncology at the European Institute of Oncology (IEO), shared an article by Xiaotian Zhang, et al. on LinkedIn:
“GEMSTONE-303 Study.
The GEMSTONE-303 trial investigated whether the addition of sugemalimab (an anti–PD-L1 monoclonal antibody) to capecitabine plus oxaliplatin (CAPOX) improves progression-free survival (PFS) and overall survival (OS) in advanced gastroesophageal junction adenocarcinoma with PD-L1 CPS ≥5.
- Overall survival (OS): 15.6 months vs. 12.6 months (HR: 0.75; P = 0.006).
- In PD-L1 CPS ≥10 patients: OS improved to 17.8 months vs. 12.5 months (HR: 0.64; P = 0.002).
- Progression-free survival (PFS): 7.6 months vs. 6.1 months (HR: 0.66; P < 0.001).
- Objective response rate (ORR) in PD-L1 CPS ≥5 patients: 68.6%, the highest among phase 3 trials.
How GEMSTONE-303 Differs from Other Trials:
- Selective Patient Population: Included only PD-L1 CPS ≥5 patients.
- Chemotherapy Regimen: Used CAPOX exclusively, unlike other trials that included FOLFOX or other IV-based regimens.
- Study Location: Conducted at 54 sites in China, enrolling 90% gastric cancer patients.
- Lower Rate of Peritoneal Metastases: 13% vs. 20–44% in other trials.
- No Maintenance Chemotherapy: Treatment stopped after 6 cycles, except for sugemalimab or placebo.
- Microsatellite Instability (MSI) Status Not Reported, despite its known impact on immunotherapy response.”
First-Line Sugemalimab Plus Chemotherapy for Advanced Gastric Cancer: The GEMSTONE-303 Randomized Clinical Trial.
Authors: Xiaotian Zhang, et al.
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